US Senate FY 2011 FDA Appropriations Bill should be another big step forward for rare and neglected disease patients, says FDA Law Blog

With the US Senate Committee on Appropriations beginning its markup and consideration of appropriations bills for Fiscal Year 2011, and in particular the Agriculture, Rural Development, FDA [Food and Drug Administration], and Related Agencies Appropriations bill (S 3606), rare and neglected disease (ie, orphan disease) advocates appear to be poised to make big gains (once again!), once again, comments Kurt Karst, writing on law firm Hyman, Phelps & McNamara's FDA Law Blog.

The FY 2011 Senate bill includes a $2 million increase (for a total of $16,035,000) for FDA's Orphan Product Development Grant program. The FY 2010 funding for the program was about $14 million, of which approximately $10 million funded non-competing continuation awards, and around $4 million of which funded 10 to 12 new awards. The FY 2011 increase is the first since FY 2005.

$1 million to fund rare diseases office at FDA